Atopic Dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: dupixent
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Dupilumab
Current Sponsor code: SAR231893
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Sanofi (China) Investment Co., Ltd, Shanhai Branch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent. - Male or Female. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Willing to refrain from applying any topical medication products on the target assessment areas throughout the study until the EoT visit unless necessary to alleviate intolerable symptoms. - Willing to refrain taking showers or soaking in a bathtub with soaps and body washes within 6 hours before TEWL assessments. - Willing to NOT apply any moisturizers to the areas of the skin that are targeted assessment areas during the entire study from Day -7 to the EoT visit. - Willing and able to comply with all clinic visits and study-related procedures. - Capable of understanding and giving signed informed consent/assent as will be described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents =12 and =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical conditions - Previous treatment with dupilumab within 6 months prior to screening. - Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the investigator (ie, skin atrophy, ichthyosis, Netherton syndrome, severe photo damage). - Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments. - Ocular disorder that in the opinion of the investigator could adversely affect the individual’s risk for study participation. Examples include -but are not limited to- individuals with a history of active cases of herpes keratitis; Sjogren’s syndrome, keratoconjunctivitis sicca or dry eye syndrome that require daily use of supplemental lubrication; or individuals with ocular conditions that require the use of ocular corticosteroids or cyclosporine. - Systemic AD treatment or phototherapy within 4 weeks of baseline. - Topical AD treatment within 1 week of baseline. Face and neck may be treated with topical steroids during the washout period if approved by the investigator. - Severe prior or concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study. Examples include, but are not limited to patients with short life expectancy, patients with uncontrolled diabetes (hemoglobin A1c =9%), patients with cardiovascular conditions (eg, Class III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, patients on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc), other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric (known suicidal intentions),lymphatic diseases, or any illness(es) that resulted in prior or current use of chemotherapy or radiation . The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, electronic case report forms [eCRF], screening logs, etc). - History of hypersensitivity reaction to tape or adhesives. Prior/concomitant therapy - Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer. - Treatment with live (attenuated) vaccine within 4 weeks before the baseline visit. Prior/concurrent clinical study experience - Current participation in another investigational clinical study. Other exclusions - Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized - Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures - Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6) - Any specific situation during study implementation/course that may raise ethics considerations - Sensitivity to any of the study interventions, or components thereof, or drug or other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after 5 skin tape stripping (STS) in pre-defined lesional skin in patients with moderate to severe atopic dermatitis (AD) treated with dupilumab;Secondary Objective: •Evaluate changes in skin barrier function with TEWL assessed before and after 10, 15 and 20 STS in pre-defined lesional skin in patients with moderate to severe AD treated with dupilumab ;Primary end point(s): Percent change from baseline in TEWL after 5 STS assessed on lesional skin at Week16 in AD patients.;Timepoint(s) of evaluation of this end point: From baseline to week16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percent change from baseline in TEWL after 5 STS assessed on lesional skin at Week16 in AD patients. Change from baseline in TEWL before and after 10, 15 and 20 STS respectively assessed on lesional skin at Week16 in AD patients;Timepoint(s) of evaluation of this end point: From baseline to week16 | — |
Countries
China
Contacts
Public Contact-
SANOFI (CHINA) INVESTMENT CO., LTD
Outcome results
None listed